Orca Bio
Regulatory Affairs Project Manager - BLA
Orca Bio, Menlo Park, California, United States, 94029
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant
has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.We're looking for an experienced Regulatory Affairs Project Manager to provide support, track and coordinate cross-functional deliverables for regulatory timelines for our upcoming BLA submission. This position can exist as an FTE or on a contract-basis depending on the needs of Orca Bio and the candidate.
Key Responsibilities
Develop and maintain overall BLA integrated project timelines.Develop and maintain dashboards to identify and monitor critical gating items in preparation of data readout.Provide PM support to Regulatory team for FDA meeting interactions including developing briefing packages for Clinical and CMC.Support CMC Regulatory in development of timelines to support possible submission amendments.Help ensure BIMO inspection readiness, including mock-inspection timelines.Ensure an appropriate level of urgency is communicated while maintaining focus on deliverables.Identify potential critical issues, constraints, bottlenecks, risks, and mitigation management (and propose solutions to support decision-making).Drive decision-making processes and escalate issues as needed.May communicate to senior leadership on a regular basis.
Desired Qualifications
Knowledge Base: Prior experience as lead project manager for BLA or NDA regulatory filings; understanding of must-haves vs. nice-to-haves for regulatory filings.Communication: Persuasively convey ideas and suggestions for forward momentum; skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies; comfortable with negotiation and challenging the status quo and bringing forward innovative solutions.Organizational: Strong attention to detail; propensity to document at the right level; able to identify roadblocks and provide direction to teams to explore alternatives.Technical: Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
Who we areWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask 'why not' and challenge the status quo.We maintain a start-up culture of camaraderie and leadership by example, regardless of title.We’re proud to be an equal opportunity employer and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients, and their healthcare providers.To learn more: https://orcabio.com/join-our-team/
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allogeneic stem cell transplant
has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.We're looking for an experienced Regulatory Affairs Project Manager to provide support, track and coordinate cross-functional deliverables for regulatory timelines for our upcoming BLA submission. This position can exist as an FTE or on a contract-basis depending on the needs of Orca Bio and the candidate.
Key Responsibilities
Develop and maintain overall BLA integrated project timelines.Develop and maintain dashboards to identify and monitor critical gating items in preparation of data readout.Provide PM support to Regulatory team for FDA meeting interactions including developing briefing packages for Clinical and CMC.Support CMC Regulatory in development of timelines to support possible submission amendments.Help ensure BIMO inspection readiness, including mock-inspection timelines.Ensure an appropriate level of urgency is communicated while maintaining focus on deliverables.Identify potential critical issues, constraints, bottlenecks, risks, and mitigation management (and propose solutions to support decision-making).Drive decision-making processes and escalate issues as needed.May communicate to senior leadership on a regular basis.
Desired Qualifications
Knowledge Base: Prior experience as lead project manager for BLA or NDA regulatory filings; understanding of must-haves vs. nice-to-haves for regulatory filings.Communication: Persuasively convey ideas and suggestions for forward momentum; skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies; comfortable with negotiation and challenging the status quo and bringing forward innovative solutions.Organizational: Strong attention to detail; propensity to document at the right level; able to identify roadblocks and provide direction to teams to explore alternatives.Technical: Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
Who we areWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask 'why not' and challenge the status quo.We maintain a start-up culture of camaraderie and leadership by example, regardless of title.We’re proud to be an equal opportunity employer and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients, and their healthcare providers.To learn more: https://orcabio.com/join-our-team/
#J-18808-Ljbffr